February 24, 2014 — The parents of a boy who took Onfi (clobazam) developed Stevens-Johnson Syndrome (SJS), a life-threatening skin reaction, have filed a lawsuit in federal court in Northern Texas. Lawyers allege that Lundbeck failed to warn about Onfi side effects and aggressively promoted Onfi for off-label uses that were not approved by the FDA.
The plaintiffs, Madeline Escareno and Rogelio Escareno, filed the lawsuit against Lundbeck Pharmaceuticals on behalf of their 11 year-old son, Antonio Escareno. The boy was prescribed Onfi “off-label” to treat epilepsy and seizures. He developed a severe adverse skin reaction to Onfi called Stevens-Johnson Syndrome (SJS), which escalated to a more severe reaction called Toxic Epidermal Necrolysis (TEN).
The skin reaction caused blistering, burning, sloughing, and peeling of the skin from a large portion of his body, including the inside and outside of his mouth, throat and genital areas. He was hospitalized for one month in March 2013, during which time he lost most of his skin, hair, and fingernails. He has suffered permanent physical disfigurement and psychological trauma.
Onfi is only FDA-approved to treat Lennox-Gastault Syndrome, a condition that affects less than 200,000 people per year in the United States. Lawyers allege that Lundbeck aggressively marketed Onfi “off-label” for all types of seizure disorders, reaping hundreds of millions of dollars in profit.
In December 2013, the FDA published a Drug Safety Communication to warn about the link between Onfi and Stevens-Johnson Syndrome (SJS). The FDA has received 6 reports of SJS/TEN in the United States and 14 foreign cases. All victims were hospitalized, one case resulted in blindness, and one person died.
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